Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) not eligible for transplant.

Official Title

A Multicenter Open-Label Phase 1b/2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Details

Phase 1b: In the dose escalation portion of the study, various cohorts with escalating doses of lenalidomide may be explored, using the 3+3+3 principle for dose determination.

Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible subjects will receive ibrutinib, lenalidomide and rituximab.

Keywords

Relapsed Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma DLBCL Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Rituximab Lenalidomide Ibrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically confirmed relapsed/ refractory DLBCL
  • Must have previously received first line treatment regimen
  • Must be ineligible for high dose therapy/ stem cell transplantation
  • Measurable disease sites on CT scan (>1.5 cm in longest dimension)
  • PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
  • Men and women ≥18 years of age
  • ECOG < 2
  • Adequate hepatic and renal function
  • Adequate hematologic function

You CAN'T join if...

  • Medically apparent central nervous system lymphoma or leptomeningeal disease
  • History of allogeneic stem-cell (or other organ) transplantation
  • Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
  • Radio- or toxin-immunoconjugates within 10 weeks
  • Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

Locations

  • UCLA Medical Center
    Los Angeles California 90095 United States
  • Cedar Sinai Medical Center
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02077166
Phase
Phase 1/2
Study Type
Interventional
Last Updated